Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

NCT00414102 | Completed Phase 4

• 2 other identifiers: 01-05-TL-375-069U1111-1115-2043
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 52

Brief Summary

The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia.

Conditions

Chronic Insomnia

Keywords

Chronic Insomnia; Sleep Initiation and Maintenance Disorder; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Average subjective Sleep Latency from Day 15 to Day 21

  Day 22

Secondary Outcomes (6)

• Subjective Measures of Sleep Latency.

  Weeks 1 and 2 or Final Visit

• Subjective Total Sleep Time.

  Weeks 1, 2 and 3 or Final Visit

• Wake Time after Sleep Onset

  Weeks 1, 2 and 3 or Final Visit

• Number of Awakenings.

  Weeks 1, 2 and 3 or Final Visit

• Quality of Sleep.

  Weeks 1, 2 and 3 or Final Visit

Study Arms (2)

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.

Also known as: TAK-375, Rozerem™

Ramelteon 8 mg QD

Placebo DRUG

Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.

Placebo QD

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Body mass index between 18 and 34, inclusive.
• Based on sleep history, has had chronic insomnia for at least 3 months.
• Based on sleep history, reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time of less than or equal to 6.5 hours.
• The difference of the average subjective sleep latency from days 1-3 to days 5-7 has to be less than or equal to 20 minutes during the single blind run-in period.
• On at least 3 of the first 5 nights of single-blind run-in placebo treatment, the subject must have an subjective sleep latency of greater than or equal to 45 minutes and subjective total sleep time of less than or equal to 6.5 hours.
• Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
• Willing to have a fixed bedtime and agrees to go to bed within 30 minutes of the habitual bedtime during the entire study.
• Consistent access to a touch-tone phone and are willing to complete all paper and telephone questionnaires within 60 minutes of awakening each morning throughout the entire duration of the study.
• Willing to remain in bed for at least 6.5 hours each night during the entire study.
• Based on sleep history, uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.

You may not qualify if:

• Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
• Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
• Has sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
• Has flown across greater than 3 time zones within 7 days prior to screening, or will travel across 2 or more time zones during the course of the study.
• Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
• Has ever had a history of seizures; sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening polysomnography.
• History of psychiatric disorder within the past 6 months.
• History of drug addiction or drug abuse within the past 12 months.
• History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or for the inpatient subject consumed any alcoholic drinks within 24 hours of any polysomnography visits.
• Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
• Uses tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle.
• Positive urine drug screen at initial screening Visit 2.
• For inpatient subjects: has a positive breathalyzer test on any of the PSG assessment visits.
• Exhibit a placebo response during single blinded placebo run in period.
• Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.

Sponsors & Collaborators

• Takeda: lead

Study Sites (52)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Los Angeles Area, California, United States

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San Diego, California, United States

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Colorado Springs, Colorado, United States

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Denver Area, Colorado, United States

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Delray Beach, Florida, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Kansas City Area, Kansas, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Auburn, Maine, United States

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Baltimore Area, Maryland, United States

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Washington D.C. Area, Maryland, United States

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Hattiesburg, Mississippi, United States

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Saint Louis Area, Missouri, United States

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Albuquerque, New Mexico, United States

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Long Island City, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

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Morganton, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Gallipolis, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland Area, Oregon, United States

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Clarkes Summitt, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston Area, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Norfolk, Virginia, United States

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Seattle Area, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Medical Director Clinical Science

  Takeda Global Research & Development Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 28, 2016

Record last verified: 2010-05

Locations

US (52)